A Safety, Tolerability and Levodopa Pharmacokinetics Study of Repeated ND0612 in Parkinson's Dise… (NCT01883505) | Clinical Trial Compass
CompletedPhase 2
A Safety, Tolerability and Levodopa Pharmacokinetics Study of Repeated ND0612 in Parkinson's Disease Patients
Israel30 participantsStarted 2014-01-06
Plain-language summary
This is a randomized, placebo-controlled, double-blind, 2-period study evaluating the safety and pharmacokinetics (PK) of ND0612 in Parkinson's disease (PD) patients on an optimized oral levodopa (LD) regimen and experiencing ≥2 h/day of OFF time. Safety and tolerability, PK profile, pump usability, and the potential clinical effect of ND0612 will be explored in subjects with PD and motor fluctuations.
Who can participate
Age range
30 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Men and women with idiopathic PD whose diagnosis was confirmed by presence of at least two of the cardinal signs (resting tremor, bradykinesia, rigidity) and lacking any other known or suspected cause of parkinsonism.
. Patients who experienced motor fluctuations averaging at least two hours daily in the "OFF" state during the waking hours (including morning akinesia), corresponding to the end-of-dose deterioration phenomenon ("wearing off") confirmed by the baseline home diaries.
. Modified Hoehn and Yahr stage \< 5 in the "OFF" state.
. Patients who were taking optimized LD/decarboxylase inhibitor therapy (based on the investigator's judgment) that was stable for at least 14 days prior to baseline. Patients were to receive at least three daily doses of LD (which could include a bedtime dose) with at least three hours between doses.
. Patients treated with dopaminergic agonists and other anti-PD drugs were to be on stable doses for at least 30 days prior to baseline and those doses were to remain constant throughout the study period.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum Dermal Rating Score: Draize Score
Timeframe: 14 days (Period 1)
2
Maximum Dermal Rating Score: Erythema and Eschar Formation
. Women who were postmenopausal, surgically sterilized, or using adequate birth control. Women of childbearing potential were to have a negative pregnancy test (beta human chorionic gonadotropin \[hCG\] serum) at screening.
. Patients between the ages of 30 and 80.
. Patients willing and able to give informed consent.
Exclusion criteria
. Patients treated with controlled release formulation of LD/CD. (Note: Patients treated with Entacapone, Tolcapone, or Stalevo were allowed to participate in Period 1 but were excluded from Period 2 participation)
. Patients with a clinically significant or unstable medical or surgical condition which would preclude safe and complete study participation. Such conditions may include gastrointestinal, cardiovascular, pulmonary, hepatic, renal, or metabolic diseases or malignancies as determined by medical history, physical exam, laboratory tests, or ECG.
. History of melanoma or significant skin disorders.
. Patients with significant cognitive impairment as defined by a MMSE score of \< 25.
. Patients treated with dopaminergic agonists, anticholinergics, monoamine oxidase (MAO)-B inhibitors, or antipsychotics that need dose adjustment in the 30 days prior to Study Baseline.
. Patients with clinically significant psychiatric illness, including major depression (according to Diagnostic and Statistical Manual of Mental Disorders \[DSM\] IV criteria for major depressive episode) or other problems that might compromise their ability to provide consent or participate fully in the study.
. Patients with a history of alcohol or substance abuse within the past two years.
. Patients who have taken experimental medications within 60 days prior to baseline.
Timeframe: Day 15 (Period 1) and Day 22 (Period 2)
9
LD Cmin
Timeframe: Day 15 (Period 1) and Day 22 (Period 2)
10
LD Cmax
Timeframe: Day 15 (Period 1) and Day 22 (Period 2)
11
LD AUC (0-10h)
Timeframe: Day 15 (Period 1) and Day 22 (Period 2)
12
Time LD Concentration >1000 ng/mL
Timeframe: Day 15 (Period 1) and Day 22 (Period 2)
13
LD Concentration FI
Timeframe: Day 15 (Period 1) and Day 22 (Period 2)